RIOMET Drug Patent Profile

Which patents cover Riomet, and what generic alternatives are available?

Riomet is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in RIOMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Riomet

A generic version of RIOMET was approved as metformin hydrochloride by ANDA REPOSITORY on January 24^th, 2002.

Summary for RIOMET

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	41
Patent Applications:	4,089
Drug Prices:	Drug price information for RIOMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIOMET
What excipients (inactive ingredients) are in RIOMET?	RIOMET excipients list
DailyMed Link:	RIOMET at DailyMed

See drug prices for RIOMET

See drug sales revenues for RIOMET

Recent Clinical Trials for RIOMET

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1
Washington State University	Early Phase 1
National Institutes of Health (NIH)	Early Phase 1

See all RIOMET clinical trials

Pharmacology for RIOMET

Drug Class

Biguanide

Paragraph IV (Patent) Challenges for RIOMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RIOMET	Oral Solution	metformin hydrochloride	500 mg/5 mL	021591	1	2018-02-02

US Patents and Regulatory Information for RIOMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003		DISCN	Yes	No
Sun Pharm	RIOMET ER	metformin hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	212595-001	Aug 29, 2019		DISCN	Yes	No	9,962,336		Y

Expired US Patents for RIOMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003	6,890,957

International Patents for RIOMET

See the table below for patents covering RIOMET around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	524519	Liquid formulation of metformin
Russian Federation	2003104808
Japan	2004505913
Australia	7659801
Slovakia	2102003	Liquid formulation of metformin

Supplementary Protection Certificates for RIOMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1261586	C01261586/02	Switzerland		PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1532149	92128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2498758	CR 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113

Market Dynamics and Financial Trajectory for RIOMET (Metformin Hydrochloride)

Last updated: July 27, 2025

Introduction

RIOMET—an oral solution of metformin hydrochloride—serves as a pivotal treatment in type 2 diabetes mellitus, particularly for pediatric populations, those with swallowing difficulties, or patients requiring flexible dosing. As a generic diabetes medication, its market positioning, growth prospects, and revenue potential are influenced by an intertwined web of clinical needs, regulatory factors, competitive landscape, and broader healthcare trends. This analysis explores the current market environment, forecasted financial trajectory, and strategic considerations surrounding RIOMET.

Market Landscape: Key Drivers and Challenges

Prevalence of Diabetes and Market Demand

The global diabetes epidemic underpins a sustained demand for effective, affordable treatments like metformin. According to the International Diabetes Federation (IDF), approximately 537 million adults worldwide had diabetes as of 2021, with projections reaching 700 million by 2045 [1]. Type 2 diabetes accounts for over 90% of cases, emphasizing the critical role of metformin-based therapies.

Specifically, pediatric and elderly populations often require alternative formulations like RIOMET. The pediatric segment, though smaller, demonstrates consistent growth due to increasing awareness and early intervention strategies.

Formulation Innovations and Patient Compliance

RIOMET offers advantages over traditional tablet forms, notably improved compliance for children and those with swallowing difficulties. Liquid formulations reduce dosing errors, support flexible titration, and enhance adherence—a factor pivotal in managing chronic conditions effectively.

Regulatory Environment and Approvals

The FDA's approval pathway for generic formulations like RIOMET involves demonstrating bioequivalence and manufacturing quality compliance. Recent regulatory trends favor increased approval of pediatric-specific formulations to align with global health initiatives. As of now, RIOMET received FDA approval in 2012, positioning it well within this regulatory ecosystem [2].

Competitive Dynamics

While generic metformin solutions face competition from other formulations, the market remains fragmented with multiple players. Mono- or multi-dose liquid formulations are produced by various pharmaceutical companies, which necessitates differentiated marketing, patent positioning, or cost advantages.

Notably, branded formulations like Glucophage™ have entrenched market share, but generics such as RIOMET leverage cost competitiveness and accessibility.

Healthcare Policy and Reimbursement Trends

Payers increasingly favor affordable generic options, bolstered by policies encouraging cost-effective management of diabetes. However, reimbursement coverage varies across regions, impacting access and sales volume. In markets such as the U.S., Medicaid and Medicare extensively cover metformin prescriptions, influencing uptake of brands like RIOMET.

Supply Chain and Manufacturing Considerations

High-quality manufacturing standards are critical to maintain regulatory compliance and product confidence. Supply chain stability and raw material costs, notably for active pharmaceutical ingredients (APIs), influence pricing strategy and profit margins.

Financial Trajectory: Revenue Drivers and Forecasts

Revenue Drivers

• Market Penetration Rate: The pace at which RIOMET gains acceptance in pediatric clinics, hospitals, and pharmacies.
• Pricing Strategy: Competitive pricing, margin considerations, and reimbursement reimbursements impact total revenue.
• Geographical Expansion: Entry into emerging markets via partnerships or subsidiaries offers significant revenue growth potential.
• Formulation Compatibility: Compatibility with combination therapies may extend usage scope.
• Patent and Market Exclusivity: As a generic, RIOMET’s revenue is primarily driven by volume rather than proprietary pricing; however, any patent extensions or formulation patents can temporarily elevate margins.

Current Market Performance and Historical Data

While specific sales figures for RIOMET are not publicly disclosed, the broader metformin market is substantial. The global oral diabetes medication market was valued at approximately USD 28 billion in 2021 and is projected to grow at a CAGR of 7%, reaching USD 45 billion by 2028 [3].

Within this context, generic formulations like RIOMET capture a significant share propelled by cost-conscious healthcare systems and the preference for tried-and-tested active ingredients.

Projection Scenarios for RIOMET

Conservative Scenario:
Limited growth due to intense competition and constrained regulatory expansion, leading to steady but modest annual revenues (~USD 50-100 million globally).

Moderate Scenario:
Expanded acceptance across multiple regions, increased pediatric usage, and strategic partnerships could elevate revenues to USD 150-250 million within 5 years.

Aggressive Scenario:
Proactive market penetration, regulatory approvals for extended indications, and entry into emerging markets may drive revenues beyond USD 300 million within a decade.

Influencing Factors

• Patent Status: As a generic, RIOMET’s profitability hinges on manufacturing costs and market penetration rather than exclusivity.
• Healthcare Trends: Emphasis on early intervention and liquid formulations enhances potential demand.
• Market Competition: Few liquid metformin options exist; however, new entrants or formulations may disrupt market share.

Strategic Considerations and Future Outlook

Market Expansion Opportunities

Emerging markets present high-growth avenues due to increasing diabetes prevalence and expanding healthcare infrastructure. Regulatory harmonization facilitates bioequivalent product approvals in regions like Asia, Africa, and South America.

Formulation Diversification

Developing extended-release or combination formulations could further enhance patient compliance, open new market segments, and improve financial prospects.

Partnerships and Licensing Agreements

Collaborations with regional pharma firms, health agencies, or hospital systems can accelerate market penetration and revenue growth.

Regulatory and Policy Risks

Changes in reimbursement policies, patent cliff risks, or regulatory shifts toward stricter generic drug standards could impact revenues.

Key Takeaways

• The global diabetes epidemic sustains robust demand for metformin formulations, including liquid options like RIOMET.
• RIOMET’s unique positioning as a pediatric and compliance-enhancing formulation affords it niche advantages within the broader generic diabetes drug market.
• Financial growth is primarily driven by increased market penetration, geographical expansion, and formulation innovation.
• Competition from other generic and branded formulations remains significant; strategic differentiation and regional partnerships are essential.
• The long-term revenue trajectory indicates potential for substantial growth, particularly through emerging markets and formulation diversification.

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FAQs

1. What is the primary market advantage of RIOMET over traditional metformin tablets?
   RIOMET’s liquid formulation improves adherence among children and patients with swallowing difficulties, making it a preferred choice in pediatric and certain clinical settings.

2. How does the regulatory environment affect RIOMET’s market growth?
   FDA approval and compliance with international regulations enable expansion into global markets, especially if the formulation gains approval in emerging regions with high diabetes prevalence.

3. What are the major factors influencing RIOMET’s revenue potential?
   Market penetration, pricing strategies, reimbursement frameworks, regional approvals, and competition dynamics are pivotal.

4. What challenges could impede RIOMET’s financial trajectory?
   Intense competition from other generics, regulatory restrictions, pricing pressures, and limited regional reach could constrain growth.

5. Are there opportunities for innovation or formulation expansion for RIOMET?
   Yes, developing extended-release versions or combination therapies can broaden its market applicability and enhance revenue streams.

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References

[1] International Diabetes Federation. (2021). Diabetes Atlas 9th Edition.
[2] U.S. Food & Drug Administration. (2012). FDA approves first generic form of metformin.
[3] MarketsandMarkets. (2022). Oral Diabetes Medication Market Analysis.

Note: Precise sales data and proprietary revenue figures for RIOMET are proprietary and not publicly available; projections are based on market trends and industry analyses.